Prevalence of Malnutrition in Surgery

• Conditions: Malnutrition; Surgery; Cancer

• Registration Number: NCT03926715
• Lead Sponsor: Società Italiana di Nutrizione Clinica e Metabolismo

Brief Summary

Nutritional disorders are highly prevalent in gastrointestinal cancer patients undergoing surgery and have shown to contribute significantly in short, mid and long-term clinical outcome. Although increasing evidence and expert suggestions there is still inadequate awareness about the clinical relevance of nutritional and metabolic alterations in surgical oncologic patients.

Detailed Description

Nutritional disorders are highly prevalent in cancer patients and have shown to contribute significantly in short-, mid- and long-term clinical outcome. The prevalence of malnutrition is reported between 25% and over 70% based on nutritional assessments. Nutritional disorders represent an important risk factor for the occurence of postoperative complications.

Main obstacles to improving nutritional care include lack of awareness for the problem among the general public and lack of awareness among decision makers and even care providers.

Considering the high prevalence of malnutrition and its repercussions in patient morbidity-mortality and healthcare cost, nutritional screening measures must be included in an integrated nutritional care plan for patients before surgery and while in the hospital.

The PRoMiS study was conceived to quantify nutritional disorders among gastrointestinal cancer patients undergoing surgery in Italy. The data obtained will contribute to increase the awareness of nutritional disorders among oncology surgical patients and their impact on clinical outcome, favoring the inclusion of the initial assessment of nutritional status before surgery and of the nutritional intervention.

Study Timeline

• Study Start: 2017-01-06
• Study First Submitted: 2018-03-17
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Study First Posted: 2019-04-24
• Last Update Posted: 2019-04-24
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)
• Diagnosis of malignant solid tumor
• Age> 18 years
• Informed consent

Exclusion Criteria

• Uncontrolled metabolic disorders
• Uncompensated heart failure
• Severe psychiatric disorders
• Appropriate logistical support for participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malnutrition	Pre-operative	Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	Hospital discharge (10-15 days)	Incidence of pneumonia, sepsis and dehiscence of the surgical wound.

Trial Locations

Locations (8)

Pof. Romario Fumagalli; 🇮🇹 Brescia, Italy

Claudio Pedrazzi; 🇮🇹 Reggio Emilia, Italy

Roberto Coppola; 🇮🇹 Rome, Italy

Antonio Gasbarrini; 🇮🇹 Rome, Italy

Giovanni de Manzoni; 🇮🇹 Verona, Italy

Leonardo De Meo; 🇮🇹 Catania, Italy

Roberto Caronna; 🇮🇹 Rome, Italy

Amilcare Parisi; 🇮🇹 Terni, Italy